PSI Gene Technology Co., Ltd.

PSI Gene Technology Co., Ltd. specializes in in vitro diagnostic (IVD) genetic testing kits. Their devices focus on hereditary eye conditions, including gene sequencing kits for predicting high myopia risk, fluorescence PCR-based kits for diagnosing corneal dystrophy (specifically TGFBI-related), and a mitochondrial gene testing kit for Leber hereditary optic neuropathy. These tools are designed to analyze genetic markers associated with these conditions.

The company is headquartered in China. This location is relevant for understanding regulatory compliance and market focus, particularly for devices intended for domestic or international distribution.

PSI Gene Technology Co., Ltd.’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion indicates their devices may be marketed or used within the EU, though registration alone does not imply authorization—individual devices must meet EU regulatory requirements (e.g., MDR or IVDR) for legal use.

All of PSI Gene Technology Co., Ltd.’s listed devices fall under the IVD General classification. This classification applies to in vitro diagnostics that pose minimal risk (e.g., genetic tests for hereditary conditions) and typically require less stringent regulatory scrutiny than higher-risk devices. Classification is determined by factors like intended use, patient risk, and diagnostic purpose, as outlined in frameworks like the EU’s IVDR.